Tolmetin sodium - Generic Drug Details

What are the generic drug sources for tolmetin sodium and what is the scope of freedom to operate?

Tolmetin sodium is the generic ingredient in four branded drugs marketed by Ortho Mcneil Janssen, Ani Pharms, Chartwell Rx, Rising, Sun Pharm Industries, Teva, and Cosette, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for tolmetin sodium. Three suppliers are listed for this compound.

Summary for tolmetin sodium

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	2,032
What excipients (inactive ingredients) are in tolmetin sodium?	tolmetin sodium excipients list
DailyMed Link:	tolmetin sodium at DailyMed

Recent Clinical Trials for tolmetin sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all tolmetin sodium clinical trials

Pharmacology for tolmetin sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for tolmetin sodium

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tolmetin sodium

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for tolmetin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074729-001	Feb 27, 1997		DISCN	No	No
Cosette	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074399-001	Mar 28, 1996		DISCN	No	No
Ani Pharms	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073519-001	May 29, 1992		DISCN	No	No
Chartwell Rx	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074002-001	Sep 27, 1993		DISCN	No	No
Chartwell Rx	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073462-001	Apr 30, 1992		DISCN	No	No
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for tolmetin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982	3,752,826
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982	3,752,826

Tolmetin sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tolmetin Sodium

Introduction

Tolmetin sodium, a non-steroidal anti-inflammatory drug (NSAID), has been a staple in the treatment of various arthritic conditions, including rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. To understand its market dynamics and financial trajectory, it is crucial to delve into its usage, competition, regulatory environment, and economic factors.

Market Overview

Indications and Usage

Tolmetin sodium is prescribed for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. Its anti-inflammatory, analgesic, and antipyretic properties make it a viable option for managing chronic arthritis[4].

Patient Base

The patient base for tolmetin sodium includes individuals suffering from various forms of arthritis. Given the chronic nature of these conditions, the demand for effective NSAIDs like tolmetin sodium remains steady. The patient population is diverse, including both adults and children (over 2 years old) with arthritis[1][4].

Competitive Landscape

Market Competition

The NSAID market is highly competitive, with several other drugs available, such as ibuprofen, naproxen, and indomethacin. However, tolmetin sodium has a niche due to its efficacy and relatively lower incidence of certain adverse effects compared to other NSAIDs. For instance, it has been shown to have fewer gastrointestinal side effects than aspirin and fewer central nervous system side effects than indomethacin[4].

Generic and Branded Versions

Tolmetin sodium is available under several brand names, including Tolectin, Tolectin DS, and Tolectin 600. The availability of generic versions has increased competition and affected the pricing strategy for the branded versions. Generic competition often leads to price reductions, which can impact the financial trajectory of the branded drug[1][4].

Regulatory Environment

FDA Approval and Guidelines

Tolmetin sodium has been approved by the FDA for the treatment of various arthritic conditions. However, it comes with black box warnings regarding cardiovascular and gastrointestinal risks, which can influence prescribing patterns and patient adherence. Regular monitoring by healthcare providers is recommended to mitigate these risks[1][5].

Contraindications and Warnings

The drug is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. These contraindications and warnings can limit its market potential and impact its financial performance[1].

Economic Factors

Pricing and Cost

The pricing of tolmetin sodium varies depending on the dosage form and the region. For example, the cost of a 600 mg tablet can range from $2.06 to $2.43 USD per tablet. The cost-effectiveness of the drug, especially when compared to other NSAIDs, plays a significant role in its market dynamics[4].

Reimbursement and Insurance

Reimbursement policies by insurance companies can significantly influence the market dynamics of tolmetin sodium. Drugs that are covered by insurance plans are more likely to be prescribed, thereby affecting sales and revenue.

Financial Trajectory

Revenue Trends

The revenue generated by tolmetin sodium has been relatively stable due to its established position in the market. However, the introduction of new NSAIDs and biologic agents for arthritis treatment has posed a challenge. The generic competition has also led to a decline in the revenue of branded versions over the years.

Profit Margins

The profit margins for tolmetin sodium are influenced by production costs, marketing expenses, and competition from generic and branded alternatives. The need to invest in research and development to improve the drug's formulation and delivery methods (e.g., fast-dissolving tablets and rectal mucoadhesive hydrogels) can also impact profit margins[2].

Innovations and Future Outlook

New Formulations

Efforts to improve the drug's delivery and bioavailability, such as the development of fast-dissolving tablets and rectal mucoadhesive hydrogels, aim to enhance patient compliance and reduce gastrointestinal side effects. These innovations can potentially boost the drug's market share and financial performance[2].

Market Expansion

Expanding into new markets, particularly in regions with growing healthcare needs, can provide opportunities for growth. However, this must be balanced against regulatory hurdles and local competition.

Key Takeaways

• Stable Patient Base: The chronic nature of arthritis ensures a steady demand for NSAIDs like tolmetin sodium.
• Competitive Market: The presence of generic and branded competitors affects pricing and market share.
• Regulatory Considerations: Black box warnings and contraindications influence prescribing patterns and patient adherence.
• Economic Factors: Pricing, reimbursement policies, and production costs impact the financial trajectory.
• Innovations: New formulations and delivery methods can enhance market position and financial performance.

FAQs

What are the primary indications for tolmetin sodium?

Tolmetin sodium is primarily used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis[4].

What are the major side effects associated with tolmetin sodium?

Major side effects include increased risk of cardiovascular events, gastrointestinal bleeding, ulceration, and perforation. Other side effects can include acid or sour stomach, belching, and stomach discomfort[1][5].

How does tolmetin sodium compare to other NSAIDs?

Tolmetin sodium has a relatively lower incidence of certain adverse effects compared to other NSAIDs. For example, it has fewer gastrointestinal side effects than aspirin and fewer central nervous system side effects than indomethacin[4].

What are the contraindications for tolmetin sodium?

Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery and should not be used in conjunction with salicylates[1][4].

How has the introduction of generic versions affected the market for tolmetin sodium?

The introduction of generic versions has increased competition, leading to price reductions and impacting the revenue of branded versions of tolmetin sodium[4].

Sources

1. RxList: Tolectin (Tolmetin Sodium): Side Effects, Uses, Dosage...
2. Unbound Medicine: Tolmetin journal articles from PubMed
3. PubMed: Tolmetin sodium, a new anti-arthritis drug: double-blind and long...
4. DrugBank Online: Tolmetin: Uses, Interactions, Mechanism of Action
5. Mayo Clinic: Tolmetin (oral route) - Mayo Clinic